THYSAT Tablet Ref.[9330] Active ingredients: Potassium iodide

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: hameln pharma ltd, Nexus, Gloucester Business Park, Gloucester, GL3 4AG, UK

Pharmacodynamic properties

Pharmacotherapeutic group: Antidotes
ATC code: V03AB21 Potassium iodide

When exposed to radioactive iodine, potassium iodide prevents damage by radioactive iodine to the thyroid gland due to saturation by non-radioactive iodine of thyroid gland preventing the uptake of radioactive iodine from contaminated air, water, milk and other foods.

IN THE CASE OF NUCLEAR ACCIDENT, IT IS NECESSARY TO ADMINISTER POTASSIUM IODIDE WITHIN ONE HOUR!

Administration within one hour results in the thyroid gland being saturated with non-radioactive iodine (more than 85%). For every hours' delay the percentage of saturation decreases: after three hours the saturation with non-radioactive iodine is 50%. Administration of the iodine after six hours of exposure is of no benefit. Therefore, it is very important that public notice of possible nuclear accident is given as soon as possible.

Pharmacokinetic properties

The human body contains 20 to 50 mg of iodine. The average daily consumption is 150 to 200 ยตg. Iodine uptake by the thyroid gland is 80-fold higher compared with other organs. The human body is able to metabolise doses even manyfold higher than the daily recommended dose, mainly via urine, enterohepatic circulation and salivary glands (after the administration of one single dose of 3 g potassium iodide the dose is completely eliminated after 75 hours, 89% via urine).

As much as a quarter of the iodine taken by the mother can be secreted in the breast milk within 24 hours. Potassium iodide can partially block transport of radioiodine in the milk. The same criteria should apply when selecting a dose of potassium iodide to protect a lactating mother as that used for other young adults under 40 years of age.

Preclinical safety data

A single high dose has been found to be teratogenic in rats. In another study in rats, the administration of high daily iodine doses led to incomplete parturition, failure of lactation and reduced mothering activities. The administration of a iodine-containing substances to pigs had no teratogenic effects.

In a long term study where rats received potassium iodide in the drinking water for two years the development of squamous cell carcinomas in the salivary glands were observed.

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